Federal Register notice: FDA has made available a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigator...
FDA Review has posted the Federal Register notices for the week ending 11/22/2019.
Federal Register notice: FDA seeks comments on an information collection extension for Certification of Identity; Form FDA 3975.
Federal Register notice: FDA sends to OMB an information collection for Medical Devices; Shortages Data Collection System.
The U.S. Justice Department announces that a Florida foundation has agreed to pay $4 million to resolve allegations that it violated the False Claims ...
CBER Office of Compliance and Biologics Quality issues RichSource Stem Cells an untitled letter over promotional statements on its Web site for cell t...
Federal Register notice: FDA seeks comments on an information collection extension for General Licensing Provisions; Section 351(k) Biosimilar Applica...